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Regulatory Affairs Manager

Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: San Francisco, California
Industry:
Salary: Negotiable
Start Date: asap
Reference: HQ00054401_1491927131
Contact Name: Pavlina Bullaj
Contact Email: p.bullaj@sciproglobal.com
Job Published: April 11, 2017 17:12

Job Description

Regulatory Affairs Manager

Overview:

  • Medical Device background
  • San Francisco Bay Area
  • Writing/ preparing & managing medical device submissions such as 510(k)
  • Good working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820

Details:

SciPro Global is currently looking for a Regulatory Affairs Manager for one of my key clients in the San Francisco Bay area. We are seeking a hands-on Regulatory Affairs Manager to supports the Company's regulatory activities across a variety of programs - the Regulatory Affairs Manager should have sufficient experience in regulatory submissions such as 510(k), PMA, IDE, De Novo as well as compliance to provide direction and guidance to R&D, manufacturing, marketing/sales to changing regulatory requirements and standards.

  • The ideal candidate would have had previous medical device experience.
  • Write, prepare, and manage regulatory submissions and filings required for U.S. FDA and other international authorities (i.e. 510(k), CE Marking, Health Canada License, etc.)
  • Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
  • Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820
  • Experience in developing, writing and submitting successful IDE/510(k)/PMA/De Novo submissions
  • Bachelor's degree in a scientific discipline; advanced degree and RAC preferred
  • Five or more years' experience in regulatory affairs with direct project and personnel management responsibilities
  • Experience in software development and software quality as it relates to regulatory submissions a plus.

This is a great opportunity for someone to join a fast growing team and dynamic team & taking the next step in your career.

If this is something you could be interested in, please apply below or alternatively send me an email with to p.bullaj@sciproglobal.com with your availability and contact details.

I look forward to speaking to you!